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FDADecember 20, 2019device

ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.

What to do

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414482446

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct. — Recall Details · AllClear